Back to resultsAdvance Care Planning in the Emergency Department
Primary Purpose
Congestive Heart Failure, Metastatic Cancer, Chronic Kidney Disease Requiring Chronic Dialysis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ED GOAL
Sponsored by
About this trial
This is an interventional supportive care trial for Congestive Heart Failure focused on measuring Advance Care Planning, Palliative Care, Goals of Care, ED GOAL
Eligibility Criteria
Inclusion Criteria:
- ≥50 years of age AND ≥1 Serious illness* OR ED clinician would not be surprised if patient died in the next 12 months (a validated prognostic sign)
- English-speaking
Capacity to consent
- Patient with mild cognitive impairment or mild dementia with capacity to consent (requires a caregiver/study partner to enroll)
- Caregiver of patient with moderate/severe dementia with capacity to consent
(*) NYHA Stage III/IV congestive heart failure, chronic obstructive lung disease on home oxygen, chronic kidney disease on dialysis, or metastatic solid tumor cancer. In addition, patients with NYHA Stage I/II congestive heart failure, chronic obstructive lung disease not on home oxygen, chronic kidney disease not on dialysis will be included if recent hospitalization in the last 12 months exists.
Exclusion Criteria:
- Acute physical or emotional distress
- Determined by treating or study clinician not to be appropriate
- Clearly documented goals for medical care** (Unless the treating or study clinician recommends that the intervention is clinically indicated)
- Delirium (assessed using 3D-CAM)
- Already enrolled in this study
- Unable/unwilling to schedule the follow-ups on the calendar
- Receive both the outpatient care for serious illness and primary care outside of the Mass General Brigham health system
(**)e.g., MOLST, medical order for life-sustaining treatment, documented serious illness conversations in clinician notes within the last 3 months, etc.
Sites / Locations
- Brigham and Women's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Arm
Control Arm
Arm Description
The intervention will take place in the emergency department or days after an emergency department visit at home/hospital virtually using zoom or phone by our trained clinicians. At the time of follow-up assessments, participants may also receive additional counseling by our trained clinicians as needed.
No intervention will be conducted (standard of care).
Outcomes
Primary Outcome Measures
Change in advance care planning (ACP) engagement with clinicians at one month
ACP engagement is a one-item question from the validated ACP engagement survey that measures participants' self-reported readiness to discuss their values and preferences with their doctors. The instrument is a 5-point Likert scale ranging from "I have never thought about it (1)" to "I have already done it (5)." A higher score indicates a better outcome.
Sudore RL, Heyland DK, Barnes DE, Howard M, Fassbender K, Robinson CA, Boscardin J, You JJ. Measuring Advance Care Planning: Optimizing the Advance Care Planning Engagement Survey. J Pain Symptom Manage. 2017 Apr;53(4):669-681.e8. doi: 10.1016/j.jpainsymman.2016.10.367. Epub 2016 Dec 29. PMID: 28042072; PMCID: PMC5730058.
Secondary Outcome Measures
Feeling heard and understood survey
A validated instrument for seriously ill patients to report how well they feel heard and understood about their wishes for end-of-life care. This instrument is a 5-point Likert scale: "not at all (1)," "slightly (2)," "moderately (3)," "quite a bit (4)," and "completely (5)." A higher score indicates a better outcome.
Gramling R, Stanek S, Ladwig S, Gajary-Coots E, Cimino J, Anderson W, Norton SA; AAHPM Research Committee Writing Group, Aslakson RA, Ast K, Elk R, Garner KK, Gramling R, Grudzen C, Kamal AH, Lamba S, LeBlanc TW, Rhodes RL, Roeland E, Schulman-Green D, Unroe KT. Feeling Heard and Understood: A Patient-Reported Quality Measure for the Inpatient Palliative Care Setting. J Pain Symptom Manage. 2016 Feb;51(2):150-4. doi: 10.1016/j.jpainsymman.2015.10.018. Epub 2015 Nov 17. PMID: 26596879.
Quality of communication survey
A validated instrument to measure the quality of communication about end-of-life care. This instrument is a 10-point Likert scale ranging from "the very worse I could imagine (0)" to "the very best I could imagine (10)". A higher score indicates a better outcome.
Engelberg RA, Downey L, Curtis JR. Psychometric characteristics of a quality of communication questionnaire assessing communication about end-of-life care. J Palliat Med. 2006 Oct;9(5):1086-98.
Healthcare utilization
Electronic medical records will be reviewed to find the number of urgent care visits, ED visits, hospitalizations, hospice visits, and outpatient visits.
Mortality
The electronic medical records will be reviewed to find the patients' vital status.
Qualitative benefits and obstacles of advance care planning (ACP) conversations after ED GOAL
Semi-structured interviews to assess the benefits of ED GOAL and obstacles participants faced in completing more ACP conversations with their outpatient clinicians and loved ones after ED GOAL.
Electronic medical record documentation of advance care planning (ACP) conversations
The electronic medical record will be reviewed to find clinician documentation of ACP conversations.
Change in advance care planning (ACP) engagement with clinicians at three months
ACP engagement is a one-item question from the validated ACP engagement survey that measures participants' self-reported readiness to discuss their values and preferences with their doctors. The instrument is a 5-point Likert scale ranging from "I have never thought about it (1)" to "I have already done it (5)." A higher score indicates a better outcome.
Sudore RL, Heyland DK, Barnes DE, Howard M, Fassbender K, Robinson CA, Boscardin J, You JJ. Measuring Advance Care Planning: Optimizing the Advance Care Planning Engagement Survey. J Pain Symptom Manage. 2017 Apr;53(4):669-681.e8. doi: 10.1016/j.jpainsymman.2016.10.367. Epub 2016 Dec 29. PMID: 28042072; PMCID: PMC5730058.
Change in advance care planning (ACP) engagement with clinicians at six months
ACP engagement is a one-item question from the validated ACP engagement survey that measures participants' self-reported readiness to discuss their values and preferences with their doctors. The instrument is a 5-point Likert scale ranging from "I have never thought about it (1)" to "I have already done it (5)." A higher score indicates a better outcome.
Sudore RL, Heyland DK, Barnes DE, Howard M, Fassbender K, Robinson CA, Boscardin J, You JJ. Measuring Advance Care Planning: Optimizing the Advance Care Planning Engagement Survey. J Pain Symptom Manage. 2017 Apr;53(4):669-681.e8. doi: 10.1016/j.jpainsymman.2016.10.367. Epub 2016 Dec 29. PMID: 28042072; PMCID: PMC5730058.
Participant-reported completion of advance care planning (ACP) conversations
Participants are asked if they had completed ACP conversations with their loved ones and clinicians.
Full Information
NCT ID
NCT05209880
First Posted
January 10, 2022
Last Updated
June 20, 2023
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05209880
Brief Title
Advance Care Planning in the Emergency Department
Official Title
An Advance Care Planning Intervention in the Emergency Department: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a two-armed, parallel-design, pre-/post-intervention assessment study. The investigators will conduct a randomized controlled trial for ED GOAL on a cohort of 120 older adults with serious illness to collect patient-centered outcomes and determine preliminary efficacy on increasing advance care planning engagement (self-reported and/or in the electronic medical record) one month after leaving the emergency department. The investigators will also conduct qualitative interviews with participants of ED GOAL.
Detailed Description
ED GOAL, a 6-minute motivational interview conducted in the emergency department (ED), which engages participants to address advance care planning (ACP) conversations with their outpatient clinicians and avoids a time-consuming, sensitive conversation in the time-pressured ED environment. This study is designed to determine the preliminary efficacy of ED GOAL on increasing ACP engagement (by self-report and in the electronic medical record) one month after leaving the ED.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Metastatic Cancer, Chronic Kidney Disease Requiring Chronic Dialysis, Chronic Obstructive Pulmonary Disease
Keywords
Advance Care Planning, Palliative Care, Goals of Care, ED GOAL
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
The intervention will take place in the emergency department or days after an emergency department visit at home/hospital virtually using zoom or phone by our trained clinicians. At the time of follow-up assessments, participants may also receive additional counseling by our trained clinicians as needed.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
No intervention will be conducted (standard of care).
Intervention Type
Behavioral
Intervention Name(s)
ED GOAL
Intervention Description
The emergency department clinician-led, behavioral intervention (ED GOAL) is designed to engage seriously ill yet clinically stable older adults in the emergency department to address their values and preferences towards end-of-life care with their outpatient clinicians. The intervention consists of an interview to discuss participants' values and preferences for end-of-life care. The participants will receive coaching on how to initiate/re-introduce discussions about end-of-life wishes with their loved ones and outpatient clinicians. The participants' outpatient clinicians will also receive a summary of what participants disclosed via email or mailed letter.
Primary Outcome Measure Information:
Title
Change in advance care planning (ACP) engagement with clinicians at one month
Description
ACP engagement is a one-item question from the validated ACP engagement survey that measures participants' self-reported readiness to discuss their values and preferences with their doctors. The instrument is a 5-point Likert scale ranging from "I have never thought about it (1)" to "I have already done it (5)." A higher score indicates a better outcome.
Sudore RL, Heyland DK, Barnes DE, Howard M, Fassbender K, Robinson CA, Boscardin J, You JJ. Measuring Advance Care Planning: Optimizing the Advance Care Planning Engagement Survey. J Pain Symptom Manage. 2017 Apr;53(4):669-681.e8. doi: 10.1016/j.jpainsymman.2016.10.367. Epub 2016 Dec 29. PMID: 28042072; PMCID: PMC5730058.
Time Frame
Change from baseline ACP engagement at one month
Secondary Outcome Measure Information:
Title
Feeling heard and understood survey
Description
A validated instrument for seriously ill patients to report how well they feel heard and understood about their wishes for end-of-life care. This instrument is a 5-point Likert scale: "not at all (1)," "slightly (2)," "moderately (3)," "quite a bit (4)," and "completely (5)." A higher score indicates a better outcome.
Gramling R, Stanek S, Ladwig S, Gajary-Coots E, Cimino J, Anderson W, Norton SA; AAHPM Research Committee Writing Group, Aslakson RA, Ast K, Elk R, Garner KK, Gramling R, Grudzen C, Kamal AH, Lamba S, LeBlanc TW, Rhodes RL, Roeland E, Schulman-Green D, Unroe KT. Feeling Heard and Understood: A Patient-Reported Quality Measure for the Inpatient Palliative Care Setting. J Pain Symptom Manage. 2016 Feb;51(2):150-4. doi: 10.1016/j.jpainsymman.2015.10.018. Epub 2015 Nov 17. PMID: 26596879.
Time Frame
Baseline & 1, 3, and 6 months
Title
Quality of communication survey
Description
A validated instrument to measure the quality of communication about end-of-life care. This instrument is a 10-point Likert scale ranging from "the very worse I could imagine (0)" to "the very best I could imagine (10)". A higher score indicates a better outcome.
Engelberg RA, Downey L, Curtis JR. Psychometric characteristics of a quality of communication questionnaire assessing communication about end-of-life care. J Palliat Med. 2006 Oct;9(5):1086-98.
Time Frame
Baseline & at 1, 3, and 6 months
Title
Healthcare utilization
Description
Electronic medical records will be reviewed to find the number of urgent care visits, ED visits, hospitalizations, hospice visits, and outpatient visits.
Time Frame
At 6 and 12 months before and 1, 6, 12 months after enrollment
Title
Mortality
Description
The electronic medical records will be reviewed to find the patients' vital status.
Time Frame
At 1, 3, and 6 months
Title
Qualitative benefits and obstacles of advance care planning (ACP) conversations after ED GOAL
Description
Semi-structured interviews to assess the benefits of ED GOAL and obstacles participants faced in completing more ACP conversations with their outpatient clinicians and loved ones after ED GOAL.
Time Frame
At 1, 3, and/or 6 months
Title
Electronic medical record documentation of advance care planning (ACP) conversations
Description
The electronic medical record will be reviewed to find clinician documentation of ACP conversations.
Time Frame
At 1, 3, and 6 months
Title
Change in advance care planning (ACP) engagement with clinicians at three months
Description
ACP engagement is a one-item question from the validated ACP engagement survey that measures participants' self-reported readiness to discuss their values and preferences with their doctors. The instrument is a 5-point Likert scale ranging from "I have never thought about it (1)" to "I have already done it (5)." A higher score indicates a better outcome.
Sudore RL, Heyland DK, Barnes DE, Howard M, Fassbender K, Robinson CA, Boscardin J, You JJ. Measuring Advance Care Planning: Optimizing the Advance Care Planning Engagement Survey. J Pain Symptom Manage. 2017 Apr;53(4):669-681.e8. doi: 10.1016/j.jpainsymman.2016.10.367. Epub 2016 Dec 29. PMID: 28042072; PMCID: PMC5730058.
Time Frame
Change from baseline ACP engagement at three months
Title
Change in advance care planning (ACP) engagement with clinicians at six months
Description
ACP engagement is a one-item question from the validated ACP engagement survey that measures participants' self-reported readiness to discuss their values and preferences with their doctors. The instrument is a 5-point Likert scale ranging from "I have never thought about it (1)" to "I have already done it (5)." A higher score indicates a better outcome.
Sudore RL, Heyland DK, Barnes DE, Howard M, Fassbender K, Robinson CA, Boscardin J, You JJ. Measuring Advance Care Planning: Optimizing the Advance Care Planning Engagement Survey. J Pain Symptom Manage. 2017 Apr;53(4):669-681.e8. doi: 10.1016/j.jpainsymman.2016.10.367. Epub 2016 Dec 29. PMID: 28042072; PMCID: PMC5730058.
Time Frame
Change from baseline ACP engagement at six months
Title
Participant-reported completion of advance care planning (ACP) conversations
Description
Participants are asked if they had completed ACP conversations with their loved ones and clinicians.
Time Frame
At 1, 3, and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥50 years of age AND ≥1 Serious illness* OR ED clinician would not be surprised if patient died in the next 12 months (a validated prognostic sign)
English-speaking
Capacity to consent
Patient with mild cognitive impairment or mild dementia with capacity to consent (requires a caregiver/study partner to enroll)
Caregiver of patient with moderate/severe dementia with capacity to consent
(*) NYHA Stage III/IV congestive heart failure, chronic obstructive lung disease on home oxygen, chronic kidney disease on dialysis, or metastatic solid tumor cancer. In addition, patients with NYHA Stage I/II congestive heart failure, chronic obstructive lung disease not on home oxygen, chronic kidney disease not on dialysis will be included if recent hospitalization in the last 12 months exists.
Exclusion Criteria:
Acute physical or emotional distress
Determined by treating or study clinician not to be appropriate
Clearly documented goals for medical care** (Unless the treating or study clinician recommends that the intervention is clinically indicated)
Delirium (assessed using 3D-CAM)
Already enrolled in this study
Unable/unwilling to schedule the follow-ups on the calendar
Receive both the outpatient care for serious illness and primary care outside of the Mass General Brigham health system
(**)e.g., MOLST, medical order for life-sustaining treatment, documented serious illness conversations in clinician notes within the last 3 months, etc.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kei Ouchi, MD, MPH
Phone
6177325640
Email
kei_ouchi@dfci.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kei Ouchi, MD, MPH
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kei Ouchi, MD, MPH
Email
kei_ouchi@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Kei Ouchi, MD, MPH
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36210436
Citation
Prachanukool T, Block SD, Berry D, Lee RS, Rossmassler S, Hasdianda MA, Wang W, Sudore R, Schonberg MA, Tulsky JA, Ouchi K. Emergency department-based, nurse-initiated, serious illness conversation intervention for older adults: a protocol for a randomized controlled trial. Trials. 2022 Oct 9;23(1):866. doi: 10.1186/s13063-022-06797-6.
Results Reference
derived
Links:
URL
https://reporter.nih.gov/search/4DqkQh5GPEqNJeo3tJ2fzQ/project-details/10252848
Description
National Institutes of Health study record
Learn more about this trial
Advance Care Planning in the Emergency Department
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